Pathophysiological Effects of Intrapleural Pressure Changes During Therapeutic Thoracentesis

Medical University of Warsaw

Status: Completed

Conditions: Exudative Pleuritis; Pleural Effusion

Treatments: Procedure: Therapeutic thoracentesis; Device: Pleural manometer; Device: Pleural catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT02192138

IPU-DIMPA-WUM14(1)

Details and patient eligibility

About

Research project objectives.

The project includes eight research hypotheses and eight corresponding study objectives. The most relevant objectives are:

• Analysis of lung function and gas exchange parameters in relation to the removed pleural fluid volume and intrapleural pressure changes.

• Evaluation of changes in lung and chest wall compliance and related changes in work of breathing during therapeutic thoracentesis and pleural fluid withdrawal.

• Study of the relationship between intrapleural pressure changes and cardiac function assessed by echocardiography and alterations in serum natriuretic peptide A and B concentration.

• Comparative analysis of the reliability of the volume-pressure curve slope prediction based on different variables measured before thoracentesis and real measurements of ventilation and intrapleural pressure during thoracentesis.

  2. Research methodology The study will be performed in 60 patients with pleural effusion planned for therapeutic thoracentesis.

Studies before thoracentesis: body plethysmography, spirometry, lung diffusion capacity (DLCO), arterial blood gases, 6 minute walk test, echocardiography, serum natriuretic peptide concentration.

Evaluation during thoracentesis: continuous measurement of tidal breathing and respiratory rate, measurement of removed pleural fluid volume and intrapleural pressure, transcutaneous measurement of PO2 and PCO2. Pleural catheter will be retained for the next 48hours to enable fluid drainage and intrapleural pressure measurement after completion of thoracentesis.

Monitoring during 48-hrs after thoracentesis: pre-thoracentesis measurements will be repeated in specific time points and compared in two subgroups (active physiotherapy to improve lung re-expansion and passive lung re-expansion).

Intrapleural pressure will be measured 24 and 48 hours after thoracentesis. Then, the catheter will be removed.

Analysis.Signal analysis and visual multidimensional analysis performed with the use of own computer programs will be the first step of the analysis. The identified relationships between the analyzed parameters should allow to form physiological, medical, and statistical hypotheses, as well to verify the analysis of previously obtained data .

Expected impact of the research project The study results will allow to define lung function, blood gases and cardiovascular function in relation to changes in intrapleural pressure. Some of these correlations had not been previously investigated. Our results may influence management standards in patients who require therapeutic thoracentesis.

Enrollment: 61 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. age 18 - 85 years,
2. pleural effusion occupying more than one third of the hemithorax on the posteroanterior chest radiograph,
3. therapeutic thoracentesis planned on the basis of signs and symptoms as well as imaging and functional studies,
4. no contraindications for thoracentesis,
5. signed informed consent for participation in the study.

Exclusion criteria

1. poor performance status requiring maximal shortening of the procedure,
2. instable hemodynamic or respiratory status unrelated to pleural effusion,
3. respiratory failure requiring mechanical ventilation.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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61 participants in 1 patient group

Therapeutic thoracentesis

Experimental group

Description:

Patients with pleural effusion who require therapeutic thoracentesis will be enrolled into the study

Treatment:

Device: Pleural manometer

Device: Pleural catheter

Procedure: Therapeutic thoracentesis